The present application relates to an external skin composition comprising a salt and a sugar as active ingredients for preventing and treating vaginosis and the use thereof.
Vaginitis is a condition that occurs especially during pregnancy in the vagina causing vaginal discharge, inflammation, and irritation, as well as, vulvar or vaginal itching. The three most common vaginal infections and diseases are also the most frequent causes of vaginitis. The three common vaginal infections include: bacterial vaginosis, vaginal yeast infection, and trichomoniasis.
The human vagina is colonized with various microbes, yeasts and germs, for example, about more than 104 numbers/ml (vaginal fluid) of Lactobacillus spp. such as, Lactobacillus crispatus and Lactobacillus jensenii, which provide a weak acidic environment ranging from pH 4.5-5.1 to protect from a microbial infection. Additionally, the vagina is a highly versatile organ that can profoundly affect the health of women and their newborn infants. It has been reported that there are many important pathogens in the vaginal niche, such as, Neiserria gonorrhea, Ureaplasma species, Mycoplasma genitalium, Streptococcus species, Escherichia coli, Chlamydia trachomatis, and Trichomonas vaginalis, etc.
Bacterial vaginosis (BV), the most prevalent and detrimental vaginosis, gives rise to malodorous vaginal discharge or local irritation of the woman with BV and is associated with several more serious adverse outcomes including preterm birth, pelvic inflammatory disease, and acquisition of HIV infection. Women with bacterial vaginosis (BV) have lost many Lactobacillus species (except L. iners) and have acquired a variety of anaerobic and facultative bacteria. Gram stains of vaginal fluid from women with BV show a loss of Gram-positive rods and their replacement with Gram-negative and Gram-variable cocci and rods. Cultures of vaginal fluid from subjects with BV typically yield Gardnerella vaginalis and a mixture of other bacteria that may include Peptosterptococcus, Mobiluncus, Bacterioides, Prevotella, Porphyromonas, Mobiluncus and Mycoplasma species. (Sujatha Srinivasan and David N. Fedricks, Review Article, The Human Vaginal Bacterial Biota and Bacterial Vaginosis, Interdisciplinary Perspectives on Infectious Diseases, Vol., 2008, Article ID 750479, pp 1-3).
There have been studies to develop effective therapies to treat vaginitis, for example, orally administrated broad spectrum antibiotics, such as, metronidazole. However, this therapy has many disadvantages, such as, antibiotic intolerance, systemic toxicity in case of long-term administration, and a probable destruction of the normal bacterial flora in the vagina. These treatments cause secondary complications, such as, a decreased number of Lactobacillus spp., an increase of vaginal pH, and a proliferation of anaerobic microbes.
Accordingly, there is a need to develop novel therapeutic compositions showing treatments with long-term activity and safety to treat vaginosis.
However, there has never been a treatment reported or disclosed on the use of a composition with a combination of salt and sugar with a therapeutic effect on vaginosis. None of the above cited references, which are incorporated herein by reference, disclose a treatment using a combination of salt and sugar.
The applicants have carried out antibacterial test, especially Gardnerella vaginalis, a main cause of vaginosis, to investigate the inhibitory effect of a combination of salt and sugar on vaginosis. The results of these tests confirmed that a combination of salt and sugar showed potent antibacterial activity.
These results and other disclosures will become apparent from the detailed disclosure of the discoveries provided hereinafter.